Toxicology is the science of safety: It is the series of procedures, both experimental and regulatory, designed to minimise the risk of harm to humans from exposure to any of the thousands of chemicals that we use every day. In this module, we will look at the basic mechanisms of how chemicals may cause harm to living organisms, and the testing procedures in place to detect such adverse effects. We will also explore how safety data is extrapolated from animal models to humans, and the important role on in vitro testing strategies in replacing animal testing. These concepts will be brought together through a case study workshop, where a real-life problem will be examined, such as cabin air contamination in aeroplanes. Through directed discussion of the relevant toxicity data, the class will come to a regulatory position, and then compare this to the outcome from the relevant regulatory body.

Module aims

To create an awareness of the scope of regulatory toxicology in relation to industrial chemicals, food additives and contaminants, pharmaceuticals and consumer products

To provide a sound understanding of the principles underlying toxicity testing and risk assessment, including concepts of the NO(A)EL, ADI, MTD

To study both acute and chronic toxicity

To provide an appreciation of the methodology and regulatory requirements for the conduct of toxicity tests to investigate acute, sub-chronic, chronic and reproductive toxicity, and special tests for genotoxicity, carcinogenicity and immunotoxicity

To illustrate mechanisms of toxicity and testing schema using specific examples

To study the mechanisms of target tissue, cell and organelle toxicity

Learning outcomes

Attributes Developed

Understand the concepts of hazard characterisation and risk assessment

CPT

Appreciate the extensive series of toxicological tests in vitro and in vivo necessary to evaluate potential toxicity, assess risk and assess safety in use of food additives, pharmaceuticals, chemicals in consumer products

KC

Understand the limitations of animals as surrogates for humans in toxicological assessment and safety assurance, and how interspecies and interindividual differences in sensitivity are accommodated

C

Understand the basic concepts underlying the development of toxicity and recognise common themes

KC

Understand the basic principles of action of a number of toxins that act upon organs central to exposure (skin), metabolism (liver) and excretion (kidney) of xenobiotics

K

Attributes Developed

C - Cognitive/analytical

K - Subject knowledge

T - Transferable skills

P - Professional/Practical skills

Module content

Indicative content includes:

• Introduction to the Regulatory Framework for chemical testing
• Introduction to Experimental Toxicology
• Mechanisms of Toxicity (oxidative stress, receptor-mediated toxicity, biopharmaceuticals, nanotoxicology, and genotoxins)
• Toxicity testing (acute, (sub)chronic, carcinogenicity, and reproductive)
• The Drug development cycle – moving from pre-clinical to clinical
• Target Organ Toxicity (nephrotoxicity, dermal toxicity, liver toxicity)
• Tutorials: Specific tutorials will be held for both the regulatory and experimental toxicology lectures, as well as a general revision tutorial and coursework feedback session

Methods of Teaching / Learning

The learning and teaching strategy is designed to:

The module uses a series of building blocks to first embed subject knowledge within the student and then develop cognitive and analytical skill to allow the correct application of this knowledge. This is achieved through the use of initial ‘concept’ lectures that are designed to impart fundamental knowledge of the area to the students. These basic concepts are then explored in a series of case study lectures, where students explore how these basic concepts are commonly applied by the professional toxicologist. The analytical phase is complimented by the coursework assignment, which comprises a critical analysis of a toxicological question or recent landmark paper. Students will be expected to not only critical engage with the relevant literature, but also to critically analyse arguments on both sides of the research area, allowing them to reach a robust conclusion.

The learning and teaching methods include:

• Lectures – 3 or 4 hours per week for 8 weeks (24 hours in total)
• Interactive tutorial session – 1 hour to address specific concepts within the module, as well as non-timetabled individual support as required
• Class discussion – A case study workshop that involves both small and large group discussion of a real life toxicology scenario will be used to reinforce the lecture content, and demonstrate how evidence is seldom complete, nor answers aboslute with regard to protecting human health. In addition, the nature of the lecture format engenders class disscussion as an integrated part of the teaching stragety

Assessment Strategy

The assessment strategy is designed to provide students with the opportunity to demonstrate

Students are assessed via both coursework and written examination. Both components are designed to allow demonstration of basic knowledge description of the underlying concepts of the toxicological mechanisms of action and the regulatory frameworks put in place to test these toxicological endpoints. In addition, cognitive/analytical skills are tested through the discussion and analysis of toxicology-related problems (for example, “based on this data, what would your advice be?, or “contrast these testing strategies and discuss their relative pros and cons”) in both the coursework and examination phase

Thus, the summative assessment for this module consists of:

· Coursework (30% module mark): 2000 word essay to be submitted approximately 5 weeks into the course). Students complete one question from a choice of three, with the questions being critical assessments of important toxicological questions, rather than simple descriptive essays

· Examination (70% module mark): 2 hour examination in which students answer two essay-style questions from a choice of five

Formative assessment and feedback

The case study workshop will allow students to put into practice concepts they have learnt, gaining feedback from both academics and peers during this process. A general revision tutorial is held at the end of the module to allow students to gain feedback on their comprehension of the total module content, and their ability to synthesis it as a whole. Finally, a specific tutorial for the coursework will be held, providing feedback on this aspect of the summative assessment

Please note that the information detailed within this record is accurate at the time of publishing and may be subject to change. This record contains information for the most up to date version of the programme / module for the 2017/8 academic year.